GDUFA Research Outcomes

Topical Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.

• All(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Physiologically-Based Pharmacokinetic Modeling to support Bioequivalence and Drug Approval

  Tsakalozou, Eleftheria

• Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance

  Tsakalozou, Eleftheria

• Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel

  Tsakalozou, Eleftheria

• Theoretical Principles and Best Practices In Vitro Permeation Testing (IVPT)

  Ghosh, Priyanka

• Promising Technologies: Continuous Skin Sampling Methods for Cutaneous PK-Based Bioequivalence Assessment

  Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank

• IVPT Data Challenges and Statistical Analysis

  Ghosh, Priyanka

• Evaluation of Cutaneous Pharmacokinetics The Past, The Present, and The Future

  Ghosh, Priyanka

• Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research

  Stinchcomb, Audra

• Characterizing In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro-In Vivo Correlation Results with Transdermal Systems

  Stinchcomb, Audra